BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 6875003 · Received September 19, 2017

    Report

    Report Number
    8010047-2017-01345
    Event Type
    Malfunction
    Date Received
    September 19, 2017
    Date of Event
    August 13, 2017
    Report Date
    September 27, 2017
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    PMA / PMN Number
    PK112680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULT. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. BUT WAS RETURNED TO OLYMPUS (B)(4). FOLLOWING ADDITIONAL HIGH LEVEL DISINFECTION AT (B)(4), THE SUBJECT DEVICE WAS SENT TO A THIRD PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. IN THE ADDITIONAL TEST, THE TESTING INDICATED NO MICROBIAL GROWTH FOR THE SUBJECT DEVICE.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING ROUTINE SURVEILLANCE CULTURING TEST BY THE FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR BACTERIA. THE CHANNELS OF THE SUBJECT DEVICE EXCEPT FOR THE AUXILIARY CHANNEL TESTED POSITIVE FOR FOLLOWING CFU OF BACTERIA. THE AIR/WATER CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA (>100 CFU / SCOPE). THE SUCTION CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR BACILLUS SP (27 CFU / SCOPE). THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR BACILLUS SP (>100 CFU / SCOPE). THE CUSTOMER REPORTED THAT THE SUBJECT DEVICE WAS REPROCESSED ACCORDING TO THE INSTRUCTION FOR USE AND THE FRENCH REGULATION. THE SUBJECT DEVICE HAD BEEN DISINFECTED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD-4 (NOT AVAILABLE IN THE U.S.) WITH PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657590 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-H190I

    Patients

    Seq Age Sex Outcome Treatment
    1